Reorientation port

ABSTRACT

Various methods and devices are provided for reorienting an implantable port. In one embodiment, an implantable port is provided and includes a base adapted to be anchored to tissue, and a housing pivotally mounted on the base and having a septum formed therein and adapted to receive fluid and to provide access to a fluid reservoir formed within the housing. In an exemplary embodiment, the housing can be pivotally mounted to the base using a ball and socket joint. For example, at least one of a distal surface of the housing and a proximal surface of the base is convex, and the other one of the distal surface of the housing and the proximal surface of the base is concave.

FIELD

The present application relates to methods and devices for reorienting aport implanted under the skin.

BACKGROUND

Obesity is a growing global concern, as the number of individualsclassified as overweight, obese, or morbidly obese continues to increaseevery year. Obesity is associated with several co-morbidities, includinghypertension, type II diabetes, and sleep apnea. Morbid obesity, definedas when a person is 100 pounds or more over ideal body weight or havinga body mass index (BMI) of 40 or greater, poses the greatest risks forsevere health problems. Accordingly, a great deal of attention is beingfocused on treating patients with this condition. One method of treatingmorbid obesity is the placement of a restriction device, such as anelongated band, around the upper portion of the stomach. Gastric bandsare typically comprised of a fluid-filled elastomeric balloon with fixedendpoints that encircles the stomach just inferior to theesophageal-gastric junction. This forms a small gastric pouch above theband and a reduced stoma opening inferior to the gastro-esophagealjunction in the stomach. When fluid is infused into the balloon, theband expands against the stomach creating further food intakerestriction or a smaller stoma opening in the stomach. To decrease thisrestriction level, fluid is removed from the band. The effect of theband is to reduce the available stomach volume and thus the amount offood that can be consumed before becoming “full.”

Food restriction devices have also comprised mechanically adjusted bandsthat similarly encircle the upper portion of the stomach. These bandsinclude any number of resilient materials or gearing devices, as well asdrive members, for adjusting the bands. Additionally, gastric bands havebeen developed that include both hydraulic and mechanical driveelements. An example of such an adjustable gastric band is disclosed inU.S. Pat. No. 6,067,991, entitled “Mechanical Food Intake RestrictionDevice” which issued on May 30, 2000, and is incorporated herein byreference. Another method for limiting the available food volume in thestomach cavity is implanting an inflatable elastomeric balloon withinthe stomach cavity itself. The balloon is filled with a fluid to expandagainst the stomach walls and, thereby, decrease the available foodvolume within the stomach.

With each of the above-described food limitation devices, safe,effective treatment requires that the device be regularly monitored andadjusted to vary the degree of affect on food intake. With bandingdevices, the gastric pouch above the band may substantially increase insize following the initial implantation. Accordingly, the stoma openingin the stomach must initially be made large enough to enable the patientto receive adequate nutrition while the stomach adapts to the bandingdevice. As the patient's body adapts to the implant, the band may beadjusted to vary the stoma size. In addition, it is desirable to varythe stoma size in order to accommodate changes in the patient's body ortreatment regime, or in a more urgent case, to relieve an obstruction orsevere esophageal dysmotility or dilatation. Traditionally, adjusting ahydraulic gastric band required a scheduled clinician visit during whicha Huber (non-coring) hypodermic needle and syringe were used topenetrate the patient's skin and add or remove fluid from the balloon.More recently, devices have been developed which enable non-invasiveadjustments of the band. An external programmer communicates with theimplant using telemetry to control the stoma diameter of the band.During a scheduled visit, a physician places a hand-held portion of theprogrammer near the implant and transmits power and command signals tothe implant. The implant in turn adjusts the stoma diameter of the bandand transmits a response command to the programmer.

During these gastric band adjustments, it has been difficult todetermine how the adjustment is proceeding, and whether an adjustmentwill have its intended effect. In an attempt to determine the efficacyof an adjustment, some physicians have used fluoroscopy with a Bariumswallow as the adjustment is being performed. However, fluoroscopy isboth expensive and undesirable due to the radiation doses incurred byboth the physician and patient. Other physicians have instructed thepatient to drink a glass of water during or after the adjustment todetermine whether the water can pass through the adjusted stoma. Thismethod, however, only assures that the patient is not obstructed at thattime, and does not provide any information about the efficacy of theadjustment or the impact of the adjustment the following day as thepatient begins to consume more solid foods. Oftentimes, physicians maysimply adopt an experimental method based upon their prior experience,and the results of an adjustment may not be discovered until hours ordays later, when the patient experiences a complete obstruction of thestomach cavity.

Another problem that can arise is the ability to handle a port, such asa fluid port, used to fluidically communicate with the gastric band toincrease or decrease the restriction the band provides. For example, inorder to introduce additional fluid to increase the restriction of thegastric band, a Huber needle must be inserted through the skin and intothe port septum. This can be difficult as the stomach anatomy is not aflat surface and the port may be angled, the port may shift locationsbeneath the skin, or the port can flip over entirely.

Accordingly, there remains a need for improved methods and devices forreorienting a port implanted under the skin.

SUMMARY

Various methods and device for reorienting a port are provided. In oneembodiment, an implantable port is provided and includes a base adaptedto be anchored to tissue, and a housing pivotally mounted on the baseand having a septum formed therein and adapted to receive fluid and toprovide access to a fluid reservoir formed within the housing. In anexemplary embodiment, the housing can be pivotally mounted to the baseusing a ball and socket joint. For example, at least one of a distalsurface of the housing and a proximal surface of the base can be convex,and the other one of the distal surface of the housing and the proximalsurface of the base can be concave. The implantable port can alsooptionally be adapted to be anchored to tissue. For example, the basecan include one or more suture-receiving members adapted to receive asuture for anchoring the base to tissue, or the base can include one ormore anchors adapted to be deployed into tissue. The implantable portcan also include additional features, such as the housing having amagnetic portion adapted to align the housing with an external magnet.

In another embodiment, an implantable port can include a base adapted tobe anchored to tissue, and a housing pivotally mounted on the base. Thehousing can have a septum formed therein and adapted to receive fluidand to provide access to a fluid reservoir formed within the housing. Amagnetic member can be coupled to the housing and it can be adapted toalign the housing with an external magnet. The magnetic portion can bedisposed around an opening in the housing having the septum.

A gastric restriction system is also provided, and in one embodimentincludes an implantable gastric restriction device configured to form arestriction in a patient, and an implantable port in fluid communicationwith the implantable gastric restriction device. The implantable portcan be configured to receive fluid from a fluid source external to thepatient. For example, a septum can be formed in a housing of the portand it can be adapted to receive fluid and to provide access to a fluidreservoir formed within the housing. The implantable port also includesa base adapted to anchor to tissue. The housing can be pivotally coupledto the base. In one exemplary embodiment, the housing is pivotallycoupled to the base using a ball and socket joint. For example, at leastone of a distal surface of the housing and a proximal surface of thebase can be convex, and the other one of the distal surface of thehousing and the proximal surface of the base can be concave. The portcan also include other features, such as a magnetic portion locatedwithin the housing. A catheter can also be included and it can extendbetween the gastric restriction device and the implantable port fordelivering fluid from the fluid reservoir of the housing to the gastricrestriction device to adjust an amount of restriction applied by thegastric restriction device.

Methods for accessing a port implanted in tissue are also provided, andin one embodiment the method can include pivoting a housing disposedbeneath a skin surface and movably coupled to a base anchored in tissue,for example, to the fascia, to position a septum formed on the housingin a desired position. In an exemplary embodiment, the method can alsoinclude inserting a needle into the septum formed in the housing, andinjecting fluid into the housing. The fluid is delivered from thehousing to a gastric restriction device coupled to the housing. Inanother embodiment, pivoting the housing can be done by attracting amagnetic portion of the housing with a magnet positioned adjacent theskin surface so as to align the housing with a needle being insertedinto the septum.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a schematic diagram of one embodiment of a restriction system;

FIG. 2A is a perspective view of a restriction device of the restrictionsystem of FIG. 1;

FIG. 2B is a perspective view of the restriction device of FIG. 2Aapplied about the gastro-esophageal junction of a stomach;

FIG. 3 is a perspective view of one embodiment of an injection port ofthe restriction system of FIG. 1;

FIG. 4 is a cross-sectional perspective view of the injection port ofFIG. 3;

FIG. 5 is a cross-sectional perspective view of another embodiment of aninjection port of FIG. 1;

FIG. 6 is a perspective view of yet another embodiment of an injectionport of FIG. 1 having a magnetic member coupled thereto for facilitatingreorientation of the port;

FIG. 7 is a perspective view of the injection port of FIG. 6 showing anexternal magnet that can be used to apply a force to the magnetic memberto reorient the port;

FIG. 8 is a perspective view of one embodiment of an injection port ofthe restriction system of FIG. 1 having one or more suture-receivingmembers adapted to receive a suture for anchoring a base of the port totissue; and

FIG. 9 is a perspective view of another embodiment of an injection portof the restriction system of FIG. 1 having one or more anchors adaptedto be deployed into tissue to anchor a base of the port thereto.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

While the present invention can be used with a variety of restrictionsystems known in the art, FIG. 1 illustrates one exemplary embodiment ofa food intake restriction system 10. As shown, the system 10 generallyincludes an adjustable gastric band 20 that is configured to bepositioned around the upper portion of a patient's stomach 40, and aninjection port 30 that is fluidly coupled to the adjustable gastric band20, e.g., via a catheter 50. The injection port 30 is adapted to allowfluid to be introduced into and removed from the gastric band 20 tothereby adjust the size of the band, and thus the pressure applied tothe stomach. The injection port 30 can thus be implanted at a locationwithin the body that is accessible through the tissue. Typically,injection ports are positioned in the lateral subcostal region of thepatient's abdomen under the skin and layers of fatty tissue. Surgeonsalso typically implant injection ports on the sternum of the patient.

FIG. 2A shows the gastric band 20 in more detail. While the gastric band20 can have a variety of configurations, and various gastric bandscurrently known in the art can be used with the present invention, inthe illustrated embodiment the gastric band 20 has a generally elongateshape with a support structure 22 having first and second opposite ends20 a, 20 b that can be secured to each other. Various mating techniquescan be used to secure the ends 20 a, 20 b to one another. In theillustrated embodiment, the ends 20 a, 20 b are in the form of strapsthat mate together, with one laying on top of the other. The gastricband 20 can also include a variable volume member, such as an inflatableballoon 24, that is disposed or formed on one side of the supportstructure 22, and that is configured to be positioned adjacent totissue. The balloon 24 can expand or contract against the outer wall ofthe stomach to form an adjustable stoma for controllably restrictingfood intake into the stomach. A person skilled in the art willappreciate that the gastric band can have a variety of otherconfigurations, moreover the various methods and devices disclosedherein have equally applicability to other types of implantable bands.For example, bands are used for the treatment of fecal incontinence, asdescribed in U.S. Pat. No. 6,461,292 which is hereby incorporated hereinby reference. Bands can also be used to treat urinary incontinence, asdescribed in U.S. Patent Application 2003/0105385 which is herebyincorporated herein by reference. Bands can also be used to treatheartburn and/or acid reflux, as disclosed in U.S. Pat. No. 6,470,892which is hereby incorporated herein by reference. Bands can also be usedto treat impotence, as described in U.S. Patent Application 2003/0114729which is hereby incorporated herein by reference.

FIG. 2B shows the adjustable gastric band 20 applied about thegastro-esophageal junction of a patient. As shown, the band 20 at leastsubstantially encloses the upper portion of the stomach 40 near thejunction with the esophagus 42. After the band 20 is implanted,preferably in the deflated configuration wherein the band 20 containslittle or no fluid, the band 20 can be inflated, e.g., using saline, todecrease the size of the stoma opening. A person skilled in the art willappreciate that various techniques, including mechanical and electricaltechniques, can be used to adjust the band.

As indicated above, the system also includes an injection port 30 forreceiving and delivering fluid to the gastric band 20. The presentinvention is particularly directed towards methods and devices forreorienting an implantable port, such as injection port 30. In oneexemplary embodiment, the implantable port can have a base adapted to beanchored to tissue, and a housing pivotally mounted on the base andhaving a septum formed therein and adapted to receive fluid and toprovide access to a fluid reservoir formed within the housing. The baseand the housing of the port can be pivotally coupled to one another toallow for reorientation of the port after the port is implanted underthe surface of the skin into tissue. Since ports tend to shift onceimplanted, the ability to reorient the port to provide fluid access isparticularly advantageous.

FIGS. 3 and 4 illustrate the injection port 30 in more detail. As shown,the port 30 has a generally conical housing 100 with a distal or bottomsurface 102 and a perimeter wall 104 extending proximally from thebottom surface 102 and defining a proximal opening 105. A person skilledin the art will appreciate that the housing 100 can have any shape andsize but it is preferably adapted to be implanted in tissue. Theproximal opening 105 can include a needle-penetrable septum 106extending there across and providing access to a fluid reservoir 108formed within the housing 100. The septum 106 is preferably placed in aproximal enough position such that the depth of the reservoir 108 issufficient enough to expose the open tip of a needle, such as a Huberneedle, so that fluid transfer can take place. The septum 106 can bearranged so that it will self seal after being punctured by a needle andthe needle is withdrawn. As further shown in FIGS. 3 and 4, the port 30can further include a catheter tube connection member 110 that is influid communication with the reservoir 108 and that is configured tocouple to a catheter, such as the catheter 50 shown in FIG. 1. A personskilled in the art will appreciate that the housing 100 can be made fromany number of materials, including stainless steel, titanium, orpolymeric materials, and the septum can likewise be made from any numberof materials, including silicone.

The port 30 can further include a base 112 having a proximal surface 114that is adapted to couple to the housing 100 and a distal surface 116that is adapted to rest on and/or anchor to tissue. The distal surface116 of the base 112 can be anchored to tissue in a variety of ways. Forexample, the base 112 can include one or more suture-receiving members130 adapted to receive a suture for anchoring the base 112 to tissue,shown in FIG. 8, or the base 112 can include one or more anchors 132adapted to be deployed into tissue, shown in FIG. 9. A person skilled inthe art will appreciate that the any technique can be used to anchor thebase 112 of the port 30 in tissue. Moreover, a person skilled in the artwill appreciate that the anchoring techniques shown in FIGS. 8 and 9 canbe used with any of the embodiments of the invention described herein.

In order to facilitate reorientation of the port 30, the distal surface102 of the housing 100 and the proximal surface 114 of the base 112 canbe configured to move relative to one another. In one exemplaryembodiment, the distal surface 102 of the housing and the proximalsurface 114 of the base 112 are adapted to pivot relative to oneanother, for example, using a ball and socket configuration. In oneembodiment, shown in FIG. 4, the distal surface 102 of the housing 100is convex and is adapted to be received within a corresponding concavesurface or cavity 117 formed in the proximal surface 114 of the base112. This allows the housing 100 to pivot relative to the base 112 toreorient the housing 100 when the base 112 is positioned on and/oranchored in tissue. In another embodiment, shown in FIG. 5, the distalsurface 102 of the housing 100 can include a concave cavity and it canbe adapted to receive a corresponding convex surface formed on theproximal surface 114 of the base 112. A person skilled in the art willappreciate that any configuration of the housing 100 and the base 112can be used as long as the housing 100 and the base 112 can moverelative to one another to allow reorientation of the port.

In use, the port 30 can be implanted under the skin and the base 112 ofthe port 30 can be positioned on and/or anchored to tissue. For example,the port 30 can be implanted just beneath the tissue surface to allow aneedle or other device to be penetrated through tissue and into the port30 to add or remove fluid from the restriction system 10. In certainexemplary embodiments, the port 30 can be implanted in the fascia. Afterimplantation, reorientation of the port 30 may be necessary as the portcan shift or flip under the skin and access to the septum 106 of thehousing 100 may be limited. The port 30 can be reoriented in variety ofways. For example, the port 30 can be manually manipulated through theskin to pivot the housing 100 relative to the base 112, thus allowing aneedle to be passed through the skin and into the septum 106 in order todeliver fluid to the fluid reservoir 108 located within the housing 100.

In another embodiment, the injection port 30 can include a magneticmember 116 coupled thereto for facilitating reorientation of the port30. The magnetic member 116 can have a variety of configurations. Forexample, the magnetic member 116 can be in the form of a cylindricalmagnet with an opening therethrough. The opening can be sized and shapedto extend around a portion of the port 30. In one embodiment, shown inFIG. 6, the magnetic member 116 is configured to be disposed around aproximal portion of the housing 100. A person skilled in the art willappreciate, however, that the magnetic member 116 can have anyconfiguration and can be disposed at any location that allows themagnetic member 116 to be used for reorienting the port 30. The magneticmember 116 can also be coupled to the port 30 in a variety of ways. Forexample, the magnetic member 116 can be unitary with the port 30 or theycan be separate components and the magnetic member 116 can be fixedly orremovably coupled to the port 30. In addition, the magnetic member 116can be formed from a single magnet, as shown in FIG. 6, or it can beformed from a plurality of magnets coupled to the port 30 in anyconfiguration. For example, if the magnetic member 116 is formed from aplurality of magnets, the magnets can be coupled to the housing 100 ofthe port 30 and spaced radially around a proximal portion of the housing100.

To facilitate reorientation of the port 30, the magnet member 116 can beused in conjunction with an external magnet 118 that is placed against askin surface. The external magnet 118 can be used to apply a force tothe magnetic member 116 coupled to the housing 100 of the port 30 toalign the external magnet 118 and the magnetic member 116. This cancause the housing 100 to pivot relative to the base 112 of the port 30to reorient the housing 100 so that the septum 106 is directed towardsthe skin surface. For example, as shown in FIG. 7, the external magnet118 can be placed over the skin at a location near the implantedinjection port 30. The external magnet 118 is positioned in such a wayas to cause reorientation of the port 30 to allow a needle to beinserted through the skin and into the septum 106 of the housing 100. Inorder to facilitate insertion of the needle into the septum 106, theexternal magnet 118 can include an opening 120 therethrough to allow theneedle to pass through the opening 120, through the skin, and into theseptum 106 of the port 30 while the magnet force maintains alignmentbetween the external magnet 118 and the magnetic member 116.

The reorientation techniques described above can be used with anyrestriction system, and can be applied to various types of ports.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present invention.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

One of ordinary skill in the art will appreciate further features andadvantages of the invention based on the above-described embodiments.Accordingly, the invention is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims. All publications and references cited herein are expresslyincorporated herein by reference in their entirety.

1. A method of accessing a port implanted in tissue, comprising:pivoting a housing disposed beneath a skin surface and movably coupledto a base anchored in tissue to change an angular orientation of acentral longitudinal axis of a septum formed on the housing relative toa central longitudinal axis of the base.
 2. The method of claim 1,further comprising inserting a needle into the septum formed in thehousing, and injecting fluid into the housing.
 3. The method of claim 2,wherein the fluid is delivered from the housing to a gastric restrictiondevice coupled to the housing.
 4. The method of claim 1, wherein thebase of the port is anchored to fascia.
 5. The method of claim 1,further comprising aligning the housing by attracting a magnetic portionon the housing with a magnet positioned adjacent the skin surface so asto align the housing with a needle being inserted into the septum. 6.The method of claim 1, wherein the base is anchored in tissue prior topivoting the housing.
 7. The method of claim 1, wherein the housing ismanually manipulated to pivot the housing relative to the base.
 8. Amethod of accessing a port implanted in tissue, comprising: positioninga magnet adjacent to a skin surface, the magnet attracting a magneticportion of a housing disposed beneath the skin surface and movablycoupled to a base anchored to tissue to change an angular orientation ofa central longitudinal axis of a septum formed on the housing relativeto a central longitudinal axis of the base.
 9. The method of claim 8,further comprising inserting a needle into the septum formed in thehousing, and injecting fluid into the housing.
 10. The method of claim9, wherein the needle is inserted through an opening formed in themagnet and through the septum to inject fluid into the housing.